Ohio Admin. Code 4729:2-1-01

Current through all regulations passed and filed through October 28, 2024

Section 4729:2-1-01 - Definitions - pharmacy interns

As used in this division:

(A) "Abandoned application" means an application for a licensure pursuant to this division where the applicant fails to complete all application requirements within thirty days after being notified by the board. An applicant forfeits all fees associated with an abandoned application. The board shall not be required to act on any abandoned application and the application may be destroyed by board staff. If the application is abandoned, the applicant shall be required to reapply for licensure, submit the required fee and comply with the licensure requirements in effect at the time of reapplication.

(B) "Addicted to or abusing alcohol or drugs" means the chronic and habitual use of alcohol or the use of a drug of abuse as defined in section 3719.011 of the Revised Code by an individual to the extent that the individual no longer can control the individual's use of alcohol or drugs, the individual is physically or psychologically dependent on alcohol or drugs, or the individual's use or abuse of alcohol or drugs endangers the health, safety, or welfare of the individual or others.

(C) "Board of pharmacy" or "board" means the state board of pharmacy established under Chapter 4729. of the Revised Code.

(D) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(E) "Compounding" has the same meaning as defined in section 4729.01 of the Revised Code and agency 4729 of the Administrative Code.

(F) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(G) "Disciplinary action," unless otherwise stated in this division, means any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction, regardless of whether the action occurred by formal proceeding, consent, settlement, or other agreement:

(1) An action to revoke, suspend, restrict, limit, or refuse to grant or renew a license, registration, or certification;

(2) A summary or emergency suspension of a license, registration or certification, of any length, and any subsequent revision to the action;

(3) An administrative fine or money penalty, taken as a result of a formal proceeding, to include any fine or money penalty connected to the delivery of health care services or taken in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, censure, reprimand, or probation;

(4) An action to reprimand or place the license, registration, or certification holder on probation;

(5) The issuance of a corrective action plan only if such issuance is in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, reprimand, probation, or surrender;

(6) The withdrawal of a renewal application for licensure, registration or certification while under investigation;

(7) The non-renewal of a license, registration or certification while under investigation or to avoid an investigation;

(8) The surrender or other relinquishment of a license, registration or certification in lieu of a formal sanction against a person's license, registration, or certificate, whether permanent or temporary;

(9) In lieu of an adverse licensure, registration or certification action, a licensing agency issues a consent order in which a person agrees not to re-apply for a license, registration, or certification in the future;

(10) An enforceable agreement not to practice or to be placed into inactive or other equivalent status while under investigation or in exchange for not conducting an investigation.

(H) "Dispense" means the final association of a drug with a patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(I) "In good standing" means a preceptor to which all the following apply:

(1) Has not been denied the privilege of supervising interns by the board;

(2) Has not been denied a license, registration or certificate by any public agency or licensing agency;

(3) Does not have a license, registration or certificate limited, suspended, or revoked by any public agency or licensing agency.

(J) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, to provide personal review and approval of all professional activities. The pharmacist providing personal supervision of an intern shall:

(1) Be readily available to answer questions of the pharmacy intern;

(2) Make appropriate in-process and end-process verifications of the activities of the pharmacy intern; and

(3) Be fully responsible for the practice of the pharmacy intern.

(K) "Pharmacist" means an individual who holds a valid pharmacist license in accordance with Chapter 4729. of the Revised Code.

(L) "Place on probation" means to take action against a license, for a period of time determined by the board, which imposes conditions or other requirements, or suspends or otherwise restricts some or all of the activities in which the licensee may engage.

(M) "Preceptor" means an individual responsible for seeing that a pharmacy intern is properly supervised and exposed to all aspects of an internship program.

(1) A preceptor shall be either:

(a) A pharmacist who holds a license to practice pharmacy that is in good standing. Unless employed by a school of pharmacy, a preceptor shall have at least one year of practice experience as a licensed pharmacist.

(b) A person who is of good moral character and is qualified to direct the practical experience in the area approved by the director of licensing pursuant to rule 4729:2-2-05 of the Administrative Code.

(2) A person may serve as the preceptor for more than one intern.

(3) Except as provided in paragraph (M)(4) of this rule, the number of interns engaged in the practice of pharmacy at any time is limited to not more than two for each pharmacist on duty, unless otherwise approved by the board.

(4) The number of pharmacy interns engaged in the administration of immunizations at any time is limited to not more than six for each pharmacist providing personal supervision.

(5) A preceptor must report to the board on the progress and aptitude of an intern when requested by the director of licensing.

(N)

(1) "Positive identification" means a method of identifying a person that does not rely solely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(O) "Practical experience affidavit" is a form provided by the state board of pharmacy used to submit evidence of practical experience for internship credit pursuant to rule 4729:2-2-06 of the Administrative Code.

(P) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.

(Q) "Readily retrievable" means that records maintained in accordance with this division shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(R) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code.

(S) "Refuse to grant or renew" means to deny original or continued licensure for a period of at least twenty-four months. After twenty-four months, or such period of time as the individual board order may require, a person licensed by the board or a person seeking to attain such status by licensure, and whose license the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license. A person that seeks to attain such status by licensure, whose license the state board of pharmacy has refused to grant or renew, must meet all requirements established by the board in rule and as may be set forth in the person's board order.

(T) "Revoke" means to take action against a license rendering such license void and such license shall not be reissued. Revoke is an action that is permanent against the licensee.

(U) "School of pharmacy" has the same meaning as a college of pharmacy or a department of pharmacy of a university, which has been recognized and approved by the state board of pharmacy in accordance with rule 4729-5-01 of the Administrative Code.

(V) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(W) "Suspend" means to take action against a license rendering such license without force and effect for a period of time as determined by the state board of pharmacy. The board may require that an individual whose license or registration has been suspended may not be employed by or work in a facility licensed by the state board of pharmacy to possess or distribute dangerous drugs during such period of suspension.

(X) "Summary suspension" means to take immediate action against a license without a prior hearing rendering such license without force and effect for a period of time as indicated in section 3719.121 of the Revised Code. The board may suspend a license issued pursuant to Chapter 4729. of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.

(Y) "Veteran" means anyone who is serving or has served under honorable conditions in any component of the armed forces, including the national guard and reserve.

Ohio Admin. Code 4729:2-1-01

Effective: 1/23/2023
Five Year Review (FYR) Dates: 4/27/2027
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28, 9.79
Rule Amplifies: 4729.01, 4729.08, 4729.11
Prior Effective Dates: 06/01/1972, 03/19/1987, 07/01/1994, 01/17/1997, 02/01/2002, 02/01/2003, 02/01/2005, 01/01/2006, 04/27/2007, 10/27/2011, 08/22/2014, 09/15/2017, 07/08/2019, 04/25/2022